CN106535954A - Device and method for providing resuscitation or suspended state in cardiac arrest - Google Patents

Abstract

Disclosed is a device for providing resuscitation or suspended state through redistribution of cardiac output to increase supply to the brain and heart for a patient, the device comprising an electrically controllable redistribution component attachable to the patient and being configured to interact with the patient to provide redistribution of the cardiac output to increase supply to the brain and heart, the redistribution component following a predefined reaction pattern based on an electrical signal, and a computer means configured to: receive a patient data which identifies physiological and/or anatomical characteristics of the patient; and provide the electrical signal for the redistribution component based on the patient data or a standard response. The device may provide mechanisms to protect the aorta and the remaining anatomy of the patient from inadvertent damage caused by the disclosed device in any usage scenario of either correct intended usage or unintended usage. Also disclosed is a method for providing resuscitation or suspended state.

Description

The apparatus and method that recovery or halted state are provided in sudden cardiac arrest

Invention field

The present invention relates to for providing recovery or halted state in sudden cardiac arrest, such as be recovered with strengthening spontaneous circulation (ROSC) or expand intervention time window so that sudden cardiac arrest patient obtain new diagnosis and therapy apparatuss can apparatus and method.

Background of invention

Cardiovascular disease accounts for the 30.9% of global death toll.Only have 1 people to survive in sudden cardiac arrest in current 10 people Institute.In industrialized country, which causes the mortality rate high compared with any other disease, and accounts for non-infectious dead in developing country 3/4ths of number of dying.In the U.S., there is sudden cardiac arrest outside about 350.000 institutes；And the case in institute is no less than this Numeral.The potentiality of improvement are very big.In 2010, cardiopathic medical treatment and nursing is spent as 273,000,000,000 dollars and the productivity in the U.S. Lose as 172,000,000,000 dollars.

To 20 century 70s early stage, before CPR (cardio-pulmonary resuscitation), defibrillation and institute, give first aid to just all existing.Automatic defibrillation list The probability of sudden cardiac arrest is treated in the introducing of first (AED) before expanding institute, and in 1980 by Brighton (Brighton) medical care Personnel successfully use AED first.Even so, our current best practices also only have make institute before and institute in have about 25 altogether Patient to 30% realizes the ability of recovery, spontaneous circulation recovery (ROSC).

The feature for being subjected to the crowd of sudden cardiac arrest is varied from.Before 10 years, extensive cohort study shows about 70% incident Had by the people of sudden cardiac arrest the Electrical Cardioversion rhythm of the heart (ventricular fibrillation or ventricular tachycardia) is just begun as first The electrocardiogram rhythm of the heart that recorded.Nowadays, multinomial large-scale cohort study is noticed only 20% in those people for be subjected to sudden cardiac arrest To 30% have can the Electrical Cardioversion rhythm of the heart as its initial rhythm.

Defibrillator from also far effective for everyone, even when layering is presented the rhythm of the heart.Roughly, Electric power cannot open the coronary artery of obturation.The hiding inducement of sudden cardiac arrest is diagnosed and is treated almost without time enough, and Even and if defibrillation will also depend on and in advance hemodynamic variables are optimized.From other patient profiles, it is understood that and Time-consuming treatment is carried out, these treatments can be saved patient vitals but cannot be implemented in the time restriction of sudden cardiac arrest at present.

The not normal change of this initial rhythm also have wide in range connotation.We can attempt to can the Electrical Cardioversion rhythm of the heart remove Quiver, but we do not have other really effective remedy measures.

CPR and defibrillation are substantially unchanged so far when its realization.Before cardiac function recovers, CPR cannot produce abundance Cerebral blood flow maintaining the survival of normal brain.This explains why sudden cardiac arrest have so high neurological sickness rate and Mortality rate.It would therefore be desirable to new method is improving the neurological final result of cerebral blood flow and sudden cardiac arrest therewith, especially If it is desirable that carrying out the trial beyond defibrillation.Even if only implementing defibrillation, the new method for improving coronary artery blood flow also may be used Improve the successful probability of defibrillation.

For example, coronary artery disease represents the most common inducement of sudden cardiac arrest outside institute, but percutaneous coronary is situated between Enter (PCI) to implement in the time restriction of existing CPR.Or, even cellosolve and CABG (coronary bypass grafting Operation) enforcement of the treatment in sudden cardiac arrest can also spend the long time.

Cooling (therapeutic low temperature) is only realizing heartbeating recovery, i.e., demonstrate,prove in the patient of so-called ROSC (spontaneous circulation recovery) It is bright useful, and do not change the Proportion of patients for whether realizing ROSC.Cooling can slow down cell requirements, so as to reduce and low supply phase For example, temperature often declines one degree Celsius to the demand of matching, brain metabolic demand reduce about 8% but its would generally take hours Temperature needed for can be only achieved and therefore be not the effective means that sudden cardiac arrest patient is transitted to definitive treatment.Till that time Wait, patient has occurred irreversible and completely neurological damage.

The such as cardiopulmonary bypass of later stage therapy or ECMO (ECMO) are no matter how excellent device have, once exceed heart With the ischemia capacity of brain, it is just no longer valid.However, can be improved by these devices recover, unfortunately, in sudden cardiac arrest this A little devices sufficiently rapidly cannot start to replace the demand to middle halted state device.

Continuing sudden cardiac arrest will cause metabolic acidosiss.Now, such as sodium bicarbonate can maintain blood pH and blood plasma is put Change the accumulation that can remove toxin.

Goal of the invention

One purpose of embodiment of the present invention is to provide a kind of device or system, and the device or system make to be subjected to heart The patient of all standing can realize laser doppler flowmeter so that cardiac massage (chest compression) more effectively maintains life-critical CNS to fill Note.Another purpose of embodiment of the present invention is to provide a kind of for providing recovery in sudden cardiac arrest patient or suspending shape The method of state.Another purpose of embodiment of the present invention is to provide a kind of apparatus and method, by the apparatus and method Ease for use and built-in security can suppress the latent lesion of cardiac output redistribution method to act on, and so that method can be carried For halted state or recovery immediately.It is also an object that a kind of apparatus and method are provided, and by the apparatus and method, can be in society Area is nearby and patient is placed in halted state by the user for receiving few training by hospital personally, so as to allow not only hospital special Before section doctor, also institute, health care professional implements this class process with other people, so as to realize the time window being significantly expanded Carry out Reverse cardiac all standing or improve the probalility of success of instant defibrillation.

In particular, the purpose of embodiment of the present invention be in the existing intervention window of about 10 to 30 minutes almost only Defibrillation and medicament administration are realized enough in the case of provide the diagnosis and treatment that cannot be provided at present to sudden cardiac arrest patient.

The content of the invention

The inventor has discovered that the subject matter during the cardio-pulmonary resuscitation (CPR) of sudden cardiac arrest patient is in these situations Under non-vital organ and tissue be poured and supply nonessential high-caliber oxygen, and brain and the heart can be particularly with CNS during this generation It is dirty for cost, relative to these non-vital organs and tissue, brain and heart are extremely sensitive to low oxygenated.The present inventors have additionally discovered that such as Fruit can by CPR during this imbalance be changed into being partial to CNS and heart perfusion, then these patients can be greatly increased and survived Chance.

However, operation intervention must be implemented sets up brain and heart preferentially perfusion and this operation in patients for normal Intervention requires surgeon's technical ability.On the other hand, rescue team member is not usually surgeon, it is therefore advantageous that can Provide favourable brain and the heart preferentially device of perfusion or system just can be brought via the extremely simple intervention for not needing surgical skills.

The present inventor is it should be appreciated that a kind of new technology apparatus and new method.Different from cannot be that heart occurs be rapid The cooling (also referred to as " seemingly-dead ") that stopping time starts fast enough, i.e., cellular metabolism is significantly slowed, it is intended that introduce new terminology " temporarily Stop state ", controlling cardiac output wherein by chest compression makes nerve injury process itself to the redistribution of brain and heart Stagnate, be in debt with the metabolism that the tissue to standing this state produces constantly increase, it is each in body so as to remain in that Individual cell survival.The use of upper abdomen aortic occlusion can make coronary artery and cerebral perfusion pressure increase about 100%, so as to reach again To survival level.We are inferred to this method by following facts：The cross pincers used in the operation of aortic aneurysm is corrected, in example Such as aortic aneurysm transplanting expansion and the simple operation foley's tube used in pelvis and trunk Wound care, and remaining organ can be This intervention is stood in certain hour.

The restriction of the perfusion that the use of vasodilation can be delivered to brain and heart to reduction has materially affect.We are most First propose to be used in combination sudden cardiac arrest master with addition potent vasoactive vasodilator (the hereinafter nitroglycerin of sodium nitroprusside or high dose) Arterial occlusion sacculus therapy, to set up the high flow conditions to brain and heart under humble circulation resistance, while by using master Caused by arterial occlusion sacculus mitigates vasodilation institute, Systemic Vascular withers.

Sudden cardiac arrest patient can be brought directly to definitiveness and be controlled by the said one used in new bridging therapy or several methods Treatment method, or bring middle intervention such as low temperature or ECMO into and subsequently enter definitive treatment method.If however, we do not invent Send as an envoy to and doctor, medical personnel and the nurse of first aid are provided to sudden cardiac arrest patient, and be not only the training doctor for receiving in-patient department Teacher grasps the mode of these apparatus and method, then these apparatus and method will stay on theory stage.Or, can be by proposal Method is used for increasing the instant resuscitating machine meeting of such as defibrillation.

The crowd for being subjected to sudden cardiac arrest frequently suffers from comorbidity atherosclerosis of aorta, cause aorta fragile, frangible and In porcelain sample.This makes it necessary to invention and can be used to implement redistribution, while at utmost protecting the intelligence of patient anatomy And the mode of safety.Therefore the replacement scheme that the constraint of abdomen outer aorta or pressing are used as endovascular technology is not present great Risk and can cause for example plaque rupture, interlayer, wall rupture or thromboembolism occur.

On the other hand, sacculus is controlled wherein in imprudence and blindly guide sacculus to lead in the case of when putting its pressure to good use Pipe can cause patient anatomy to damage, especially in urgent sudden cardiac arrest situation.If only giving core by artificial estimation It is real, then foley's tube cursorily (although these accidents are extremely rare) can terminate at aortic bifurcation, the blood vascular system of such as aorta In interlayer between each layer of the venous blood tube side of system, aorta wall or the tissue chamber outside vascular system.

In order to improve existing redistribution method and cause non-medical practitioner or semi-skilled practitioner, such as rescue team Etc. redistribution that can be with high safety, therefore the present invention provides a mean for kinemic redistribution to increase in first aspect To patient's brain and device or the system supplied to provide recovery or halted state of heart, the device includes

- automatically controlled or manual redistribution component, described automatically controlled or manual redistribution component are attached to patient and are configured to Interact with patient to provide kinemic redistribution so as to increase the supply to brain and heart, the redistribution component is based on telecommunications Number predetermined reaction pattern is followed, and

- machine element, which is configured to：

O receives the patient data of the physiology and/or anatomical features of identification patient；And

O is based on patient data or normal response is provided for controlling to redistribute component and/or for physiology is presented to user And/or the signal of telecommunication of anatomical features.

When being automatically brought into operation, redistribution is for example grasped based on the generic threshold value for directly not relating to concrete patient by predetermined value Making, but this effect being equally capable of achieving in this case using manual operation, redistribution is manually controlled (such as by handss Dynamic operation locking device, such as sacculus) with response to measured value.Due to automatically controlled or manual redistribution component, and machine element The ability of patient data is received, the device can cause to realize dividing again in the case of in view of individual actual aorta specification Cloth.In this process, machine element provides telecommunications to redistribution component (or data are presented to the device of its operator) Number ability make it possible to be directly based upon the patient data of reception and predetermined reaction pattern to control to redistribute component.Therefore, The device is advantageously implemented safe program, its Computer based on being not only understanding to patient, also to redistribution group The understanding of part and interact with patient.Therefore, compared to the program implemented based on the understanding directly perceived to patient manually, the intervention is Measurable and repeatable.

For example, the device is contemplated that the actual placement situation of conductor housing, i.e. conduit are in desired location or whole Terminate in and hinder inaccessible unexpected position.

In the context of the present invention, term " redistribution " is intended to indicate that such a intervention (preferably machinery intervention), should Intervention guarantees that cardiac output is preferentially oriented to brain and heart with to the well-off hemoperfusion of the two organs, and sacrifices to having The perfusion of other organs of height supply sensitivity is not presented in limit time span.

Term " halted state " mean receive treat sudden cardiac arrest patient in, god is made by controlled redistribution The state that Jing damage process is stagnated.

In the context of the present invention, term " transition " is intended to indicate that the intervention time window for allowing to expand patient is paid a home visit to allow Patient is transported to another physical location from a physical location and/or allows patient to exist by disconnected and treatment time and/or permission Shift between the nursing of different professional teams.

In the context of the present invention, term " attaching " is intended to indicate that the tissue-device for allowing a kind of following interface Connection：Outside patient, on patient, through the interface in puncture or operative site and implantation patient.

Due to it is automatically controlled or it is manual redistribution component and be configured to based on patient data provide the signal of telecommunication machine element Between combination, device of the invention becomes able to be conducive to risk to mitigate factor.

Automatically controlled or manual redistribution component is attached to patient so that its interaction becomes unrelated with user's error.Redistribution group The example of part includes aorta after balloon, patient's tilting gearing and can provide any other dress of blood redistribution in patients Put.

Using the replacement scheme of this component be include aorta retroperfusion pump or by aorta retroperfusion pump group into Redistribution component.There may be relatively large volume of oxygenation blood in peripheral blood vessel, and make the blood volume be available for heart and brain to make With the chance for being remarkably improved survival.

Redistribution component can be interacted with patient by following predetermined reaction pattern to provide cardiac output redistribution, and this is anti- Pattern is answered to mean that specific control signal provides clear and definite and expected result.Consequently, it is possible to be based on patient data by computer The signal of telecommunication of offer makes it possible to realize safer and more predictable treatment.

Machine element is may include for example with the memory member of so-called flash memory form or containing can re-define data Or the similar computer storage of fixed data.Memory member may include the predetermined electrical signals as the response to patient data Definition.

In an example, predetermined definition is to determine the function of the signal of telecommunication, or the telecommunications of the function as patient data Number represent, and in another example, the form that predetermined definition is represented using the signal of telecommunication containing respective patient data.

Patient data for example can be included selected from following parameter：Aortic blood pressure, ABF, sudden cardiac arrest are lasting Time, exhalation CO₂, ECG, blood pressure, pressing speed and depth, pulse, respiratory frequency, cardiac output redistribution degree, tremulous pulse O₂It is full With degree or concentration, brain or periphery saturation, temperature, the fluid applied, the medicine applied, biochemical data and ultrasound wave into Picture.

The signal of telecommunication can control the function of redistribution, and which affects patient in a controlled manner and is reflected in patient data.

Device can also include the patient for being configured to generate patient data during closed cardiac massage is implemented to patient Data generation components, the patient data generating unit are configured to sense the bio signal generation patient's number from patient According to.The example of these bio signals is for the aortic pressure that for example generates during cardiac compression (cardiac massage) or for example in heart The ABF generated during pressing.

Therefore, patient data generating unit can be configured to sense the bio signal from blood vessel or tissue chamber.Patient Data generation components may include one or more pressure and/or flow transducer, including such as conventional pressure sensor and ability The flow rate-measuring device of domain known type.

In one embodiment, redistributing component includes aortectasia component, such as with for by balloon nestles In aorta and the automatically controlled or manual expansion that can expand when for example expansion fluid medium the is introduced and/active of guiding parts Arteries and veins sacculus.In other words, can be adapted to be can be for user's manual operation for swelling part；This will normally require that device by automatic shape The value received by the device of formula informs user.However, in the device/system of most user friendly form, swelling part is adapted For being automatically brought into operation.

In particular, redistribute the elongate body that part may include to extend between near-end and distal end.Herein, distal end It is to can be inserted into that end in patient's body, and near-end is to stay in that external end of patient.Redistribution component may also include Aortectasia component is connected to for expanding the swelling part of aortectasia component, such as conventional pump is such as used for flowing Body medium pumps into roller pump or piston pump in expansion.

Expansion fluid medium can be liquid or gaseous matter, such as saline solution or helium.

Described device may also include adaptable mechanism of organization protection, and the mechanism is configured to：

- blood pressure or blood flow present in patient vessel is determined during cardiac compression；

- aortectasia of the degrees of expansion for limiting aortectasia component is determined based on the blood pressure that determined or blood flow Component specification；And

- aortectasia the component specification according to determined by provides the signal of telecommunication for controlling swelling part.

Expansion feature can be the pressure in such as expansion, and which can be the expansion stream being introduced in expansion The volume of body medium, or which can be represented by deformation degree of expansion etc..

Adaptable mechanism of organization protection can be configured to be multiplied with predetermined factor based on the blood pressure or blood flow that are determined, The factor for example during cardiac compression in the range of 1.0 to 1.2 times of aortic blood pressure, determines that aortectasia component is special Levy.

If redistribution component is aortectasia component, then the signal of telecommunication can for example specify the degree of expansion；Expansion Regularly, i.e., when the expansion should expanded；Aortectasia component expands the persistent period；And/or aortectasia structure The timing of the contraction of part, i.e., should reduce heart output when the expansion is shunk to allow blood to flow through expansion The redistribution degree of amount.

Therefore described device can be included for specifying the part of the degrees of expansion of expansion, the portion for expanding timing Part, the part for determining the expansion persistent period and/or the part for expansion member contraction timing.In an embodiment In, any these parts are based on patient data and are controlled by with reference to the definition of above-mentioned predetermined electrical signals.

Described device may also include position release mechanism, and the mechanism includes determining raw specific to the aorta of patient At least one first sensor of thing signal and it is configured to examine position of the expansion in aorta based on bio signal Electronic circuit.At least one first sensor for example can include pressure transducer or flow transducer or force transducer or Any other bio-signal sensor being discussed herein.

First sensor can be located on redistribution component to determine the biological letter in aortectasia component distal position Number.In general, the part is located at the position in aortectasia component distally or is connected to that to be placed in aortectasia component remote The component of side.

Described device can be configured to reference to the data from the sensor positioned at other positions using from the first sensing The data of device, for example, be positioned at least one other of bio signal of the measure in the position of aortectasia component nearside Sensor, for example, be attached to the sensor of redistribution component.In general, the other sensors can be placed on first sensor Tail end.

From the data of first and other sensors can be diastolic pressure or systolic pressure or its can be pressure, power, distance, Width, volume and/or flow.

Position release mechanism can be configured to determine that whether aortectasia component is located in position below：Meet Pulsation blood vessel as patient sustainer, do not meet pulsation blood vessel as aorta, it is uncertain whether as patient sustainer Pulsation blood vessel, vein blood vessel, the tissue chamber of non-vascular, the uncertain tissue chamber in position.For example, position safe machine Structure can so that it is determined that whether aortectasia component is located in renal artery, in EV tissue, in the blood vessel of non-master tremulous pulse, and Optionally determine when to be placed in aorta.

Described device is may additionally include in aortectasia component or in the second sensor of expansion nearside.

Described device can be configured with data of the acceptance from least one of the first and second sensors to control The feedback circuit of the filling of aortectasia component processed.The feedback circuit can for example control aortectasia component flow, Volume, distance, width, power and/or pressure, the hereafter filling of control member, the pressure to reach as sensing on component With the pressure of the standard product in predetermined factor or interval.

Described device may also include the first fail-safe mechanism, and the mechanism is configured to determine in aortectasia component Pressure simultaneously determines the volume of aortectasia component, the ratio determined between pressure and volume by the ratio and upper lower threshold value ratio Compared with, and control sequence is performed, the control sequence includes that the further expansion for terminating aortectasia component or aorta expand Open the contraction of component.

Control sequence can be performed within one section of such as 10 to 20 seconds or longer time.Or, filling meeting can due to component Correct blood vessel or tissue this problem of chamber can be not in and stopped immediately, or be reversed immediately.

Described device may also include user interface for using swelling part can selection operation, such as control knob, which is straight The operation of control swelling part is connect so that healthcare practitioners can start the expansion or shrinkage of expanding part on demand.

Described device may include the shutdown interface of the manual optional contraction for allowing aorta expansion member, and the shutdown interface Can be configured within a period of time, such as predetermined number of seconds such as 1 to 10 second or contraction is performed in the longer time.This can cause relatively to put down The less cardiac function for shrinking and therefore protecting patient of sliding and stress.

Described device may include patient's states monitor, and which is configured to determine the life for representing that spontaneous circulation recovers (ROSC) Thing signal simultaneously controls aortectasia members contract based on the signal for being determined.

Described device may also include electronics human interface, and which has the aorta being configured to supply with patient sustainer The instruction relevant with filling extent of the position of expansion or the figure or Audio user interface of information.The user interface can be The instruction relevant with the placement of the aortectasia component in patient sustainer and device and patient are configured to supply for example The figure and/or Audio user interface of feedback of status.Such as " during filling is carried out ", " Balloon Occlusion success " or " conductor housing is being led Outside tremulous pulse.Recall and try again ".If manual operation redistributes component and/or occlusion component, then the instruction for being provided can User will be supplied to the details of state that is more detailed and for example will can making great efforts with regard to redistribution.

Device of the invention can provide the expansible structure in arteries by using at least one sensor The anatomy of the placement situation of part is examined, and at least one sensor is used for determining in expandable members or patient vessel Or the pressure of fluid in tissue, flow and/or the significant pressure of volume, flow and/or volume data.

User interface can be communicated with sensor, and based on the signal from sensor, described device is can determine that in patient's body The conjunction feelings position of the expansion in body simultaneously provides the user with instruction based on the conjunction feelings position via electronics human interface.

Machine element for example can be configured to be compared pressure, flow and/or volume data and reference input data Relatively and based on this relatively examining aortectasia component position in the body.That is, when expansion has the initiative in arteries and veins During desired location, relevant pressure, flow and/or volume data should be in certain expection upper limits and lower limit.If which exceeds this Expected limit, then user can learn that expansion may be not in tram or estimate just in injured patient and therefore stopped Only.If described device finds another position corresponding to predetermined pressure, flow and/or volume data, then user Ke get Know (for example represent by the figure of aorta and expansion and learn) which position is probably physical location.Therefore, originally The device of invention may include the interactive mode of the information for being configured to supply relevant with the position of the aortectasia component in patient Human user guiding piece, described information are determined based on the pressure, flow and/or volume data.

Machine element subsequently can be determined by continual analysis pressure, flow and/or volume data the size of blood vessel and Type, and position activation fail safe has been examined for some in body, so as to terminate redistributing interacting for component and patient.

Machine element is available to be entered data to determine and deliver the minimum institute that aortectasia component completes to redistribute Need to impact and perform the redistribution.

Therefore the present invention can provide the device with built-in security mechanism, and the built-in security mechanism is used for examining intervention, There is the latent lesion caused by expansion in not right time and position to suppress the occlusion balloon in patient, so as to not only make Internist, also trained field first aid person can grasp " halted state " technology.This will make it possible to realize one kind New intervening mode, is that new opportunity is started in the treatment that can not possibly be completed in the existing time window of 10 to 30 minutes.It is rapid in heart Stopping time once proves that initial defibrillation and Drug therapy are invalid, just can starting time extension intervention.

In particular, described device can be used by such as below scheme, specifically：

1) may initiate and sustained manual or automatic before tissue protective agent such as recombinant human erythropoietin is applied Chest compression.2) attempt to patient's defibrillation.3) sudden cardiac arrest cannot be reversed.Determine the aortic occlusion device using safety.4) Device for opening.Safe aortic occlusion is given by equipment mechanism.5) situation that hematodinamicss are improved after obturation It is lower to attempt again to patient's defibrillation.6) if it fails, may then apply vasopressor such as vassopressin.This is based on all standing Such as anaphylactic reaction of hypothesis inducement and the clinical decision made.Periodically repeat dispenser.Vasodilation may be applied Such as sodium nitroprusside.This is based on for example intractable coronary artery disease of inducement is assumed and the clinical decision made.May be periodically The arbitrary medicine of repetitive administration and/or the administration before use device.7) sudden cardiac arrest cannot reverse=>Patient is placed in time-out by decision State.9) possible application head inclines 30-90 degree downward or upward.10) 2 degrees Celsius of saline solutions of possible application Ink vessel transfusing, in body Application surface cooling cushion, low temperature total liquid ventilation and/or administration muscle relaxant on body.12) vasodilation may be applied Such as sodium nitroprusside is improving halted state microcirculation.Administration vasodilation may be repeated cyclically.13) it is transported to specialist Center.14) initiate to be in hospital cardiopulmonary bypass, ECMO or directly deliver such as PCI treatments.15) plasmapheresiss or saturating may be implemented Analysis.16) realize that patient heartbeats recover with other possible modes.17) it is further continued for cooling down 24 hours after heartbeating recovery.18) exist Patient outcome is predicted after the perennial treatment of at least 72 hours.19) with appraisal at the beginning when such as end-tidal that is just attached CO2, aortic pressure or trend-NIRS measurement apparatus continue monitoring treatment.

In order to further enhance safety and provide for example relevant more with the position of the aortectasia component in body Details, device may include the part for ultrasonic imaging.Can be used to instruct user from the data of these parts.

If aortectasia component is aortic occlusion sacculus, then described device may include for example to use saline with liquid Or gas (including such as helium or CO2) is filled aortic occlusion sacculus and measures the part of aortic pressure and balloon pressure. In interesting embodiment, described device also includes handheld unit, and the handheld unit includes machine element and filling Part and attach to aortic occlusion sacculus.In another interesting embodiment, described device also includes human interface Unit, the unit include filling component and attach to aortic occlusion sacculus that the human interface optionally attaches and suffering from Fixed position on person and wherein described human interface optionally with human interface mentioned above or with handheld unit collection Into.In both cases, aortic occlusion sacculus can be attached to handheld unit in advance.

The machine element can be configured not only to by electric control signal communicate component to redistribution, and also receive from The input data of redistribution component.Redistribution component may include sensor function, for example, illustrate failure or provide for control again The related data of distribution component.These data may include to indicate that expansion is not enough, redistribute the data of component service condition, for example The expansion for obtaining and number of contractions.

Described device may also include the component for attaching to patient and being configured to patient's application of fluid and medicine.These Fluid and applying for medicine can be controlled by the machine element of device, and the feedback with regard to fluid or medicament administration can be via above-mentioned Electronic user interface is provided.

For can for example be configurable for applying timing and controlled quatity by fluid and medicament administration to the component of patient Fluid and/or medicine.

Described device may also include additional assemblies, be selected from following component：Patient monitor, vital sign monitoring Device, wrist-watch, external chest compression device, respirator, ECG monitors, defibrillator, pacemaker, pH measurement apparatus, ultrasonic unit, ECMO/ECLS devices, body chiller, charge pump, gas analyzer for CO2, ventricular assist device, dialysis apparatuss, touch screen And telecommunication installation.When the integrated defibrillator of described device, an interesting embodiment is in the conduit of delivery locking device Including at least one electrode, which is allowed in conduit (i.e. the inside of blood vessel such as aorta) and the outside being for example placed on front thoracic wall Voltage difference is set up between electrode.

Redistribution component is may include for making patient incline along a downward-sloping direction or for making patient with head appearance upwards The inclined part of gesture.Former part can make the blood pressure in redistribution chamber (redistribution compartment) sometimes Advantageously raise, and latter part can relax the resistance suffered by the venous blood for leaving brain and heart.Depending on patient's How physiological function is showed in this novel therapeutic, and both parts are favourable for the patient in redistribution state.

Described device is may also include for self-checking system, double circuit and the part using event data record.

In interesting embodiment, the device of the present invention can receive the signal that sudden cardiac arrest or cardiac output are reduced, Or the state that state or cardiac output of the patient in sudden cardiac arrest are reduced itself can be sensed, described device can be by independent Component or increase blood flow and/or pressure to patient's cranium side to respond the shape by a part for device in intravascular State.In other words, in this embodiment, described device is adapted to be and is permanently present in (be implanted into) in patient's body (usually It is possible to be subjected to the patient of sudden cardiac arrest).In this embodiment, described device may be in response to blood pressure and/or blood flow and/or Heart rate is reduced and/or any other correlation of sudden cardiac arrest indicates and be automatically obtained cardiac output to redistribute with priority of supply heart And brain.In this embodiment, in particular it is preferred that described device matches somebody with somebody cooperation with such as cardiac pacemaker or other implanting device Further to improve the chance of survival.Eligibly, described device can send letter of the patient in the state to external source Number, such as position and take care of patient to point out EMS.

During inserting, if correctly not implementing each program step and completing the step before next program starts Suddenly, then there may be security risks.Particularly the above-mentioned thin of redistribution component is constituted in one embodiment in insertion During long main body, it is ensured that coherent insertion method is particularly important.

Therefore, described device may include to be configured to be attached to patient and be configured to point at least five different operating stages The aorta detection of operation and penetrating member, the stage include that blood vessel detection-phase, blood vessel pierce through stage, blood vessel insertion rank Section, ductal ectasia stage and the stage of recognition.Can store with stage relevant data and subsequent when the next stage is implemented Use.

The machine element of the device/system of the present invention can be adapted to be and at least one other treatment and/or monitoring dress Put the operational coordination of the device to allow the therapy equipment and according to any one of the preceding claims that communicates.This at least one Other treatment and/or monitoring device are preferably chosen from cardiac resynchronization therapy device, cardioverter defibrillators and cardiac pacemaker.

The method of the present invention

Such as be evident that from claim, the device of present invention description can be used to carry in human heart arrest victim For recovery or the method for halted state, methods described include making patient to receive cardiac massage (chest compression, this can be manually or sharp Completed with mechanical breast press device), while guaranteeing that cardiac output is redistributed preferentially to brain and heart blood supply；Such as from claim It will also be apparent that, these methods for describing in detail in the claims are not necessarily required to the device using the present invention.

In the process, redistribution is typically completed by least one of following：

The aorta of-inaccessible left subclavian artery tail end；

- make patient's head downwards or head is inclined upwardly to reach with respect to the horizontal plane into the angle between 30 and 90 degree；

- put on outside pressing force on abdominal part and/or thigh and/or arm to reduce the outside pressing force distally Perfusion；

- submissively raise leg to reach with respect to the horizontal plane into the angle between 30 and 90 degree.

Methods described at least one of can be treated with following patient and be combined：

- application of fluid, including saline and buffer such as bicarbonate,

- vasopressor is applied, including vassopressin and analog,

- apply tissue protective agent, such as erythropoietin；

- apply anti-arrhythmic, such as amiodarone；

- body temperature is reduced, such as cool down, cool down in vitro or use by using calm arteries and veins fluid infusion, psychrophore, per nasal evaporation Temperature control perfluocarbon implements total liquid ventilation.This optionally repeats according to fixed order.

Therefore, methods described preferably includes the aorta by inaccessible left subclavian artery tail end and even more preferably leads to Crossing is used for this purpose to complete redistribution by apparatus of the present invention.For example, can by by the present invention device be introduced in aorta, Preferably via femoral artery, and subsequently by expanding the redistribution component reduction of described device or interrupting the blood in redistribution component distally Flow is completing obturation.In this embodiment it is preferred that, in response to indicating the obturation of the described device in patient sustainer The measurement result of degree and correct placement, redistribution component are expanded in a controlled manner.As above in the device that the present invention is discussed When it is pointed as, the obturation and place can fully automated or manual operation.Measurement result is selected generally from：

The persistent period that-redistribution component expansion is used；

- through the blood flow of redistribution component；

The blood pressure in-redistribution component distally, optionally in combination with the blood pressure of redistribution component nearside；

- redistribute component distally and preferably in its neighbouring aorta O₂Saturation, optionally in combination with redistribution component nearside Tremulous pulse O₂Saturation.

Preferably, the expansion of component is redistributed by controlling manually or described to avoid by the machine element control of device Device is disposed or degrees of expansion is incorrect, and will according to right by activation in the case where the incorrect placement of described device is examined Ask fail safe described in 9 to control, so as to interrupt the expansion of redistribution component to allow subsequently correct placement.Come in a broad sense Say, methods described preferably includes to avoid mode and the measure of the incorrect redistribution of blood flow.

In certain embodiments, redistribution temporarily interrupts the institute to guarantee patient body by regular or irregular interval There is part fully to be irrigated.However, due to the spontaneous expansion of the blood vessel not irrigated in part of body during redistributing, institute Carefully performing, it means that it is probably difficult to re-establish redistribution state.

The method of the present invention can be carried out during one or more or serves as following one or more transition following：Treatment Property low temperature；Angioplasty, including PCI and angiography；Dialysis；Medicine such as vasopressor, Thrombolytic Drugs is applied (such as fibrinolytic Agent), fluid, bicarbonate, antidote and anti-arrhythmic；Using ultrasound wave, X-ray, CT or MR；Intubation；Mechanical ventilation； Ventricular assist device；Heart transplantation, transplants including artificial heart；Operation, performs the operation including CABG and valve surgery；Blood transfusion；Place Outside or inside pacemaker or ICD；Catheter ablation；Thromboendarterectomy；Defibrillation；Transport；ECMO；ECLS and cardiopulmonary Bypass.In other words, methods described can be combined with any one in many other methods being usually used in recovery.

Methods described may also include by using vasodilation (being sodium nitroprusside or nitroglycerin in detail below) and repeat Applying sodium nitroprusside or nitroglycerin (hereafter repeating by interval of 2-10 minutes) reduces the limit to being delivered to the perfusion of brain and heart System.This can prevent from being withered by Systemic Vascular caused by vasodilation institute with combining using aortectasia component.

The method of the present invention can also with using it is following any one combine：Actively pressing-decompression CPR, impedance threshold device, Apply adenosine, the controlled pauses of CPR (for example pressing 20 seconds, subsequently stop pressing 20 seconds).

For by kinemic redistribution to increase supply to brain and heart to sudden cardiac arrest or will heart The people of all standing provides the correlation technique of the present invention of recovery or halted state to be included making patient receive external chest compression, while guaranteeing to lead to The aorta for crossing inaccessible left subclavian artery tail end completes kinemic redistribution, and including by using vasodilation (being sodium nitroprusside or nitroglycerin in detail below), hereafter repeats to reduce to being delivered to brain and heart with 2-10 minutes as interval The restriction of perfusion.The method also acts as following one or more transition：

ECMO；ECLS；Cardiopulmonary bypass；Angioplasty, including PCI and angiography；Dialysis；Therapeutic low temperature, Hereinafter referred to as calm arteries and veins fluid infusion, psychrophore, per nasal evaporation cooling, external cooling or total liquid ventilation；Apply medicine, Hereinafter vasopressor or vasodilation, hereinafter sodium nitroprusside or nitroglycerin, Thrombolytic Drugs (such as cellosolve), fluid, carbon Sour hydrogen salt, antidote, organization protection's agent and anti-arrhythmic (such as amiodarone)；Using ultrasound wave, X-ray, CT or MR；Insert Pipe；Mechanical ventilation；Ventricular assist device；Operation, performs the operation including CABG and valve surgery；Blood transfusion；Place outside or inside pace-making Device or ICD；Catheter ablation；Thromboendarterectomy；Heart transplantation；Defibrillation；Transport.

For by kinemic redistribution to increase supply to brain and heart to sudden cardiac arrest or will heart The people of all standing provides recovery or second correlation technique of halted state to be included making patient receive external chest compression, while guaranteeing to pass through Continue abdominal compression or abdominal part constraint completes kinemic redistribution, and including by using vasodilation, in detail below For sodium nitroprusside or nitroglycerin, the limit to reduce the perfusion to being delivered to brain and heart is repeated with 2-10 minutes as interval hereafter System, and including serving as following one or more transition：ECMO；ECLS；Cardiopulmonary bypass；Angioplasty, including PCI and blood Pipe visualization；Dialysis；Therapeutic low temperature, it is the arteries and veins fluid infusion of hereinafter referred to as cooling down, psychrophore, per nasal evaporation cooling, external cold But or total liquid ventilation；Medicine, hereinafter vasopressor or vasodilation is applied, hereinafter sodium nitroprusside or nitric acid is sweet Oil, Thrombolytic Drugs such as (cellosolve), fluid, bicarbonate, antidote, organization protection's agent and anti-arrhythmic (such as amiodarone)； Using ultrasound wave, X-ray, CT or MR；Intubation；Mechanical ventilation；Ventricular assist device；Operation, including CABG operations and valve handss Art；Blood transfusion；Place outside or inside pacemaker or ICD；Catheter ablation；Thromboendarterectomy；Heart transplantation；Remove Quiver；Transport.

During the development of the present invention, inventors have appreciated that the blood vessel realized by apparatus of the present invention is received Control is inaccessible to have widely application.

For example, when the patient to bleeding profusely implements operation, should not be by traditional approach (as pressed or suturing stream The blood vessel for entering) interrupt and bleed, because the vascular system of some patients may be excessively fragile and/or hardens and do not allow to use these Method.In these patients, it is believed that introduce effective in principle and operate similar to aortectasia as discussed above Component, but size is selected to expand and the safely inaccessible locking device compared with thin vessels, it is possible to provide and anti-Hemostatic Oral Liquid is arrived Up to the much smaller mode of the wound of the wound area of bleeding.

So in an individual aspect of the present invention, there is provided for terminating during tissue or organ surgery or reducing described Tissue or organ hemorrhage method, methods described include by locking device insert to it is described tissue or organ blood supply blood vessel, its Described in the reversible expansion of locking device with the inaccessible blood vessel and wherein will be put in blood vessel wall by the locking device expanded Pressure is adapted between 1 and 2 times of the vascular pressure of locking device difference.

In general, the pressure put on by the locking device expanded in blood vessel wall is adapted to into the blood vessel across locking device At most 1.5 times of pressure differential, such as at most 1.3 times, at most 1.2 times and at most 1.1 times；Important goal to be reached is not wound blood Tube wall, and in certain embodiments, locking device are expanded to and be just or a little higher than pressure be enough to prevent blood from flowing through blood vessel In the device point.

Locking device typically will including or be attached at least one vascular pressure sensor, the vascular pressure sensor can be surveyed Vascular pressure in the fixed blood vessel.This pressure transducer can be placed in the blood vessel the inaccessible position in the blood vessel Put between the tissue or organ, and/or be placed in a part for the blood vessel, the part is by inaccessible with the tissue Or organ separates.In the first case, when pressure transducer no longer measures the fluctuation of vascular pressure, locking device just fills Divide expansion, in second situation, be equal to or a little higher than vascular pressure for measuring when the pressure in blood vessel wall is put on by device When, locking device is just fully expanded.

In the embodiment relevant with the present invention, there is provided the method for terminating or reducing tissue or organ hemorrhage, under During such as operation or the tissue or organ occur other situations of bleeding, methods described is included locking device (such as text The device of the present invention) insert to the tissue or organ blood supply blood vessel in, the reversible expansion of wherein described locking device is with obturation The blood vessel and wherein the pressure put on by the locking device expanded in blood vessel wall is adapted between the blood across locking device Between 1 and 2 times of pipe pressure difference.In this embodiment, make use of the identical pressure measxurement and control for defining apparatus of the present invention System, but pressure measxurement is interpreted the different purposes of offer, that is, induce organ hemorrhage all standing.Advantage is that the blood vessel being blocked for will not Excessive stress is born, so as to prevent the injured blood vessel under these operations.

Specific embodiment

Below, embodiment of the present invention will be described in greater detail with reference to the drawings, in the accompanying drawings：

Fig. 1 illustrates device of the invention；

Fig. 2 illustrates the function of device of the invention；

Fig. 3 illustrates user interface；

Fig. 4 illustrates digital sense component；

Fig. 5 illustrates software function；

Fig. 6-7 illustrates aortectasia component；

Fig. 8 illustrates the user interface screen on PC；

Fig. 9 illustrates the placement in people；

Figure 10 illustrates the attachment of device and limbs of patient；

Figure 11 illustrates retrograde pump；And

Figure 12 a-12e illustrate the device of implantation.

It will be evident that other scope of applications of the present invention from described in detail below and specific embodiment.However, should manage Solution, describes in detail and although specific embodiment indicates the preferred embodiments of the invention, but only provides by way of illustration, because For the variations and modifications that those skilled in the art obviously will belong in the scope of the invention from the detailed description.

Using the device shown in Fig. 1, such as the algorithm structure according to Fig. 2 is implemented and the mankind with reference to shown in Fig. 3 The mode of user interface work, implements kinemic redistribution during sudden cardiac arrest.

Fig. 1 illustrates device 1, the device contain piston pump, fluid container, the power supply with battery, CPU, RAM, with confession The memorizer of the computer program code that CPU is used and the motor component for running the driven by power of piston pump.

The device can be recovered or temporary to provide by the supply for redistributing cardiac output to increase to patient's brain and heart Stop state.The device of diagram includes automatically controlled or manual redistribution component, and which adopts and is adapted to pass through femoral artery blood conduit (femoral Arterial line) and the form of the occluding catheter subassembly 2 of insertion.

Occluding catheter promotes kinemic to divide again by reducing the blood flow across the sacculus expanded in aorta Cloth simultaneously thus increases the supply to brain and heart.

The device is adapted to be for being automatically brought into operation.CPU is configured to receive identification patient's physiology and/or anatomical features Patient data and be based on the patient data or normal response and provide for controlling redistribution component and/or life being presented to user The signal of telecommunication of reason and/or anatomical features.In the illustrated embodiment, occluding catheter includes two sensors, and one in sacculus Top, one in sacculus, or below sacculus.Sensor can specifically pressure transducer, which may be provided in this paper quilts It is considered as the blood pressure of patient data.These patient datas can be generated during for example implementing to press outside the heart to patient.

Signal from sensor is transferred to CPU, and the CPU checks conduit actively based on computer program code control Position in arteries and veins and the patient safety in device during use, and control the filling of sacculus.CPU is so as to based on from sensor The signal of telecommunication follow predetermined reaction pattern.

The device has the screen 3 for constituting a user interface part.User interface also includes control knob and passes through LED And/or the visual feedback that text importing is given.As shown in fig. 1, user interface may inform the user that when be filled, and Also may inform the user that Balloon Occlusion success and therefore cardiac output redistributes success or conduit not in aorta in required Position.

Digital sense conduit sub-component can be by designing shown in Fig. 4 a and Fig. 4 b.Fig. 4 a are transverse views and Fig. 4 b are vertical Direction view.Sensor relative to conduit structure and position can be as is also shown in fig. 4.

Catheter main body includes the elongated tubular 4 with inner chamber 5, saline can two-way flow in the lumen, that is, flow in and out ball Capsule, and wherein sensor unit 6,7 and pickup wire 8 can be passed through the length of catheter main body as shown in Figure 4.Catheter main body can It is made up of the PEBAX with 75cm active lengths.Sensor is separated by sealing (such as glue) 9.

Sacculus (not shown) can be made up of low hardness polyurethane, and which has the wall thickness of 0.05mm, the overall length of 30mm and depending on filling out The diameter of the 20-40mm of degree is filled, with least fracture pressure of 500mmHg.

Sacculus can be configured for the aorta of inaccessible patient in size.

Sensor can be MEMS class pressure transducers, such as MEMS pressure sensor MEM2000 (Metallux Switzerland)。

Sensor can be interfaced with printed circuit board (PCB) via USB.USB connections allow signal through digital processing and are used as schemed The input of the software algorithm shown in 2 and Fig. 5.

Described device also includes controller assemblies.Controller assemblies may include：The thin film of the band LED used for user interface Keyboard, integrated circuit, pump (hereinafter such as piston pump or roller pump), battery, and for controlling, powering or operating according to this Any other additional assemblies of bright device.

Figure 11 shows another embodiment of the invention.In this embodiment, the conduit tube component 15 of device is also wrapped Include and communicated come the retrograde pump 16 for controlling by CPU contained in the external component 17 with device.The pump can be brushless type pump, such as Derive from Maxon, the brushless EC6 motors of Maxon precision motors Inc..The pump is located in aorta 18.

Opening insertion apparatus that can be by positioning and piercing through femoral artery and by defining and conduit subassembly is inserted into patient Aorta in.Described device can be used to piercing through and placing program and these programs can be integrated in described device.Described device User can be helped to avoid causing undesirable incident of injury to patient by the active safety mechanic mode shown in Fig. 5.

The controller assemblies of device can be fixed pad attachment for example, by the circulating type bottom bands of trouser legs or viscosity or be fixed on the lower limb of patient Portion 10.Figure 10 is shown Case.In two embodiments, conduit 14 is extended in aorta by the port for sealing.

In another embodiment of the present invention, device can be implanted into patient.The device can by device and pacemaker, ICD is similar to working without line coordination and power transmission between implantable cardiovascular diagnosis or treatment medical treatment device, such as Figure 12 a- Shown in 12e.

Figure 12 a illustrate the heart 19 for carrying out signal communication with pacemaker/ICD 20 and redistribution component 21.In Figure 12 b and In Figure 12 c, redistribution component is pump, and in Figure 12 d and Figure 12 e, redistribution component is occlusion balloon 22.

In another embodiment of the present invention, described device as robot pierce through and insertion system a part, So as to further reduce the space of user's error.

Expected, the system includes above configuration and the change of pattern.

Embodiment 1

The operation of apparatus of the present invention

Starter or started by opener by pressing the button out, such as by release and device and battery Between circuit attachment.User takes out conduit and inserts the catheter into patient.After user completes the program, expansion is just pressed, and Examine pattern in system in-position.

Position verification pattern

When the correct standard in position is met, indicator " the correct √ in position " starts flash green and indicator " pumping ⊙ " Start to flash gold-tinted, subsequent system enters actuator (expansion) pattern.

If not up to correct position or if losing correct position, then indicator " pumping ⊙ " stops flicker, Sound alarm and " reattempting to placement × " starts flicker, until pressing expansion again.

Actuator (expansion) pattern

Actuator is activated and sacculus expansion.When the standard that sacculus is full of is reached, actuator stops, indicator " pumping ⊙ " stops flicker gold-tinted and enters self-adjusting pattern.

If the non-conformance with standard after a minute, or user presses retraction button, then enter collapsed mode, then " weight New try placement × " starts to flash and be remain on until pressing expansion again.

Self-regulated integral pattern

Indicator " sacculus full of-◆ " start flash green.Self-regulated integral pattern is according to standard by the pressure controlling in sacculus To correct pressure.

If standard cannot be kept, alarm of sounding, into collapsed mode, then " reattempts to placement × " and starts flicker Until expansion is pressed again, or if user presses retraction button, then into collapsed mode.

Collapsed mode

Indicator " pumping ⊙ " starts to flash gold-tinted.Actuator is activated and sacculus shrinks.

When sacculus shrinks, " sacculus contraction-◆ " start to flash blue light, until user presses expansion again.

Vocabulary

As shown in figure 1, P1 is pressure transducer 1, and P2 is pressure transducer 2.

Resettlement standard

Maximum pressure measured by P1 is higher than have higher than 5mmHg's between 15mmHg and the maximum and minimum pressure that measures Difference.50Hz.

Filling standard

P2 reaches pressure × 1.20 that P1 is measured.50Hz

Self-adjusting standard

P2 is still in following scope：(P1 × 1.10) to (P1 × 1.30).0.1Hz.

Described device can utilize following vision and/or audible signal to notify user：

Message A：" in filling.Continue CPR.”

Message B：Placement is reattempted to ".Sacculus is sky now.”

Message C：" aortic occlusion success.”

Message D：" contraction is completed.”

Embodiment 2

Simulation experiment

The model of mankind's ascending aorta, aortic arch and femoral artery,common is made with silicone rubber.The model is immersed in the water And the water column via connection applies internal pressure (100mmHg) in a model.Manually apply pressure simulation breast to the sacculus of attachment Portion presses.

From corresponding to left femoral artery,common model part in opening insertion test device with allow tip reach corresponding to The position of renal artery just nearside.Expand occlusion balloon, while record is from catheter tip and from sacculus chamber interior MEMS pressure sensor data.

It is verified, placement and the obturation of redistribution conduit can be controlled and is examined by using software-hardware integrated mechanism.Example Such as, having the initiative corresponding to catheter tip in arteries and veins in the filling process of (and being for example well placed in renal artery by mistake), measuring Correct pressure allows to carry out Stress control with the expected filling by the pressure change for running into sacculus.In other words, such as phenolphthalein Guan Wei is placed on tram, then the result that the filling of sacculus can run into aortic pressure and obtain is measured at sophisticated place Pressure drop is to zero rather than is maintained at the level of aortic pressure.

Embodiment 3

Experiment in vivo

Prototype plant is tested in two pilot scale animal experiments.Healthy Denmark farm pig of the animal for 30-38kg, utilizes Pentobarbital (Mebumal) 50mg/ml, 6mg/kg/h and ketamine (Ketaminol vet) 100mg/ml, 15mg/kg/h make Which is calm.Return the unfractionated heparin (unfractionated heparin) that animal applies 2000 units.

23% oxygen is set to before sudden cardiac arrest to animal mechanical ventilation and by oxygen level.During testing, with 2l/ The infusion velocity of h persistently supplies saline (0.9%NaCl) to animal.

9V DC are directly applied by the electrode pair heart introduced via right jugular vein and induces sudden cardiac arrest.By sudden cardiac arrest It is defined as systolic pressure<25mmHg is continued above 5 seconds.

ROSC is defined as into aortic systolic pressure>60mm Hg maintain the pulsation rhythm of the heart of at least 5 minutes.

Using through the Ink vessel transfusing quantifier of the right carotid linked with aorta and quiet into center cavity in aortic arch Ink vessel transfusing quantifier in the right jugular vein of arteries and veins, determines arteriotony, venous pressure and heart rate.

Numbering is that 1 pig has following baseline value before induction sudden cardiac arrest：Heart rate 85bpm, arteriotony 98/ 63mmHg, venous pressure 15mmHg.After induction sudden cardiac arrest, pig is maintained at and continues 1 minute without flow regime.Then use 2 devices of LUCAS (Physiocontrol) carries out mechanical breast pressing and continues 5 minutes again.Sudden cardiac arrest is maintained totally 6 minutes in pig Afterwards, prototype plant is introduced by aorta by right femoral artery.The parameter measured after 6 minutes sudden cardiac arrests is as follows：Heart rate is 0bmp (in the case where the machinery of 100 pressing/minutes is arranged), blood pressure are 34/23mmHg, and central venous pressure is 20mmHg.Then beat Drive prototype plant and allow which to act on 1 minute.Determine as follows with regard to 1 minute value persistently using prototype plant：Heart rate is 0 (100 Under the machinery setting of secondary/pressing/minute), central aortic blood pressure is 59/28mmHg, and central venous pressure is 22mmHg.

Therefore the use of prototype plant confirms central aortic pressure and also coronary perfusion pressure and cerebral perfusion pressure The increase of power, increases to 59mmHg from Syst 34mmHg, and continuous intravenous infusion pressure increases to 22mmHg from 20mmHg.Heart Center Parameter coronary perfusion pressure during recovery is calculated as between systole central aortic pressure and central venous pressure Difference.Therefore we are able to verify that coronary perfusion pressure increases 164%.

Numbering is the pig identical condition that 2 pig receives with numbering is 1, but by going out from right femoral artery before treatment is initiated Blood causes loss of blood (700ml) and realizes sudden cardiac arrest.

Numbering is that 2 pig has following baseline value before induction sudden cardiac arrest：Heart rate 105bpm, arteriotony 96/ 42mmHg, venous pressure 12mmHg.After loss of blood, these values are：Heart rate：93bpm, arteriotony：35/20mmHg, in Calm pulse pressure：10mmHg.Start treatment.After treatment 1 minute, value is changed into：Heart rate：95bpm, arteriotony：55/ 30mmHg, central vein blood pressure：10mmHg.

Therefore, by using the prototype of the present invention, arteriotony increase 57% is realized, and is obtained coronary perfusion pressure and is increased It is big by 80%.

Claims (69)

1. it is a kind of for by kinemic redistribution to increase the supply to patient's brain and heart providing recovery or suspend The device of state, described device include

- automatically controlled or manual redistribution component, described automatically controlled or manual redistribution component are attached to the patient and are configured to Interact with the patient to provide the kinemic redistribution so as to increase the supply to the brain and heart, it is described to divide again Cloth component follows predetermined reaction pattern based on the signal of telecommunication, and

- machine element, the machine element are configured to：

The patient data of zero physiology and/or anatomical features for receiving the identification patient；And

Zero is based on the patient data or normal response is provided for controlling the redistribution component and/or for presenting to user The signal of telecommunication of the physiology and/or anatomical features.

2. device according to claim 1, wherein described machine element include memory member, the memory member Define with the predetermined electrical signals as the response to the patient data being stored therein.

3. device according to claim 1 and 2, which includes being configured to implementing the closed cardiac massage phase to the patient Between generate patient data patient data generating unit, the patient data generating unit be configured to sensing from described The bio signal of patient generates the patient data.

4. device according to claim 3, wherein described patient data generating unit be configured to sense from blood vessel or The bio signal of tissue chamber.

5., according to device in any one of the preceding claims wherein, wherein described redistribution component includes aorta retroperfusion Pump or by aorta retroperfusion pump group into.

6. the device according to any one of claim 1-4, wherein described redistribution component be included in near-end and distal end it Between the elongate body that extends, the distal end can be inserted into the patient, and wherein described redistribution component includes aortectasia component It is used for expanding the swelling part of the aortectasia component with the aortectasia component is connected to.

7. device according to claim 6, wherein described swelling part is adapted to be can be by user's manual operation.

8. the device according to claim 6 or 7, wherein described swelling part are adapted to be and can be automatically brought into operation.

9. the device according to any one of claim 6-8, which also includes adaptable mechanism of organization protection, described adjustable Suitable mechanism of organization protection is configured to：

- blood pressure or blood flow present in the patient vessel is determined during cardiac compression；

- blood pressure based on the measure or blood flow determine that the aorta of the degrees of expansion for limiting the aortectasia component expands Open component specification；And

- signal of telecommunication for controlling the swelling part is provided according to the aortectasia component specification of the determination.

10. device according to claim 9, wherein described adaptable mechanism of organization protection are configured to based on the survey Fixed blood pressure or blood flow are multiplied with predetermined factor and determine the aortectasia component specification.

11. devices according to any one of claim 6-10, the wherein described signal of telecommunication specify the aortectasia structure The degrees of expansion of part, the timing of the expansion of the aortectasia component, the upper limit of expansion, the expansion of the aortectasia component Open the timing of the contraction of persistent period and/or the aortectasia component.

12. devices according to any one of claim 6-11, wherein described swelling part include piston pump or roller pump.

13. devices according to claim 6-12, which also includes position release mechanism, and the position release mechanism includes energy Enough determine at least one first sensor of bio signal specific to the aorta of the patient and be configured to based on described Bio signal examines the electronic circuit of position of the expansion in aorta.

14. devices according to claim 13, wherein described at least one first sensor include pressure transducer.

15. devices according to claim 13 or 14, wherein described first sensor be located at it is described redistribution component on Determine the bio signal in the position in the aortectasia component distally.

16. devices according to claim 15, wherein described device are configured to reference to from the biography positioned at other positions The data of sensor are using the data from the first sensor.

At least one of 17. devices according to claim 16, wherein described other sensors are located at the redistribution The bio signal on component with measure in the position of the aortectasia component nearside.

18. devices according to any one of claim 13-17, wherein described position release mechanism are configured to determine that institute State whether aortectasia component is located in position below：Meet pulsation blood vessel as the patient sustainer, no Meet pulsation blood vessel as the aorta, uncertain whether as the aorta of patient pulsation blood vessel, quiet Arteries and veins blood vessel, the uncertain tissue chamber of the tissue chamber of non-vascular and position.

19. devices according to any one of claim 13-18, its be additionally included in the aortectasia component or The second sensor of the expansion nearside.

20. devices according to any one of claim 13-19, wherein described device are configured with reception from institute The data of at least one of the first and second sensors are stated to control the feedback circuit of the filling of the aortectasia component.

21. devices according to any one of claim 6-20, which also includes the first fail-safe mechanism, and described first loses Effect protection mechanism is configured to the pressure determined in the aortectasia component the body for determining the aortectasia component Product, determines the ratio between the pressure and the volume, and the ratio is compared with upper lower threshold value, and performs control sequence Row, the control sequence include the receipts of further expansion or the aortectasia component for terminating the aortectasia component Contracting.

22. devices according to any one of claim 6-21, which also includes user interface for using the bulge Part can selection operation.

23. devices according to any one of claim 6-22, which includes allowing the manual of the aorta expansion member The shutdown interface of optional contraction.

24. devices according to claim 23, it is described that wherein described shutdown interface is configured to the execution in predetermined number of seconds Optional contraction.

25. devices according to any one of claim 6-24, which includes patient's states monitor, the patient's states prison Survey device to be configured to determine the bio signal for representing that spontaneous circulation recovers (ROSC), and the signal control based on the measure is described The contraction of aortectasia component.

26. devices according to any one of claim 6-25, which also includes electronics human interface, electronics mankind circle Face is relevant with the position of the aortectasia component in the patient sustainer and filling extent with being configured to supply Instruction or information figure or Audio user interface, the human interface optionally attaches the fixed bit on the patient In putting.

27. devices according to any one of claim 6-26, its also include at least one sensor, described at least one Sensor is used for determining in the aortectasia component or the patient vessel or the pressure of fluid in tissue, flow And/or the significant pressure of volume, flow, O₂Saturation or concentration and/or volume data.

28. devices according to claim 27, wherein described machine element be configured to by the pressure, flow and/ Or volume data is compared with reference input data and compares to examine the aortectasia component in body based on described In position.

29. devices according to claim 27 or 28, wherein described machine element are configured to continual analysis institute State pressure, flow and/or volume data to determine the size and type of blood vessel.

30. devices according to any one of claim 27-29, wherein described machine element are configured to based on sensing Device data analysiss have examined position or limit activation fail safe for some in body, so as to terminate the redistribution component Start with the interacting of the patient, the expansion of the aorta component or the contraction of the aorta component.

31. devices according to any one of claim 27-30, wherein interactive human user guiding piece are configured to carry For the information relevant with the position of the aortectasia component in the patient, described information is based on the pressure, flow And/or volume data is determining.

32. according to device in any one of the preceding claims wherein, and which is additionally included in described user guided lower for ultrasound wave The part of imaging data.

33. include selected from following parameter according to device in any one of the preceding claims wherein, wherein described patient data： Aortic blood pressure, ABF, sudden cardiac arrest persistent period, exhalation CO₂, ECG, blood pressure, pressing speed and depth, arteries and veins Fight, respiratory frequency, cardiac output redistribute degree, aorta O₂Saturation or concentration, brain or periphery saturation, temperature, administration Fluid, the medicine applied, biochemical data and ultrasonic imaging.

34. devices according to any one of claim 5-30, wherein described aortectasia component include that aorta is closed Plug sacculus.

35. devices according to claim 34, which is also included for filling the aortic occlusion ball with liquid or gas The part of capsule.

36. devices according to claim 35, which also includes handheld unit, and the handheld unit includes the calculating Machine part and the filling component and attach to the aortic occlusion sacculus.

37. devices according to claim 35, which also includes human interface's unit, and human interface's unit includes described Filling component and attach to the aortic occlusion sacculus, the human interface optionally attaches consolidating on the patient Positioning put and wherein described human interface optionally with the human interface defined in claim 26 and/or claim The handheld unit defined in 36 is integrated.

38. devices according to claim 36 or 37, wherein described aortic occlusion sacculus are attached to the handss in advance Hold formula unit.

39. according to device in any one of the preceding claims wherein, wherein described machine element be configured to receive from The input data of the redistribution component.

40. according to device in any one of the preceding claims wherein, and which also includes attaching to the patient and being configured to To patient's application of fluid and the component of medicine.

41. devices according to claim 40, which also includes fluid and/or the portion of medicine for applying timing and controlled quatity Part.

42. according to device in any one of the preceding claims wherein, and which is also included selected from following additional assemblies：Patient-monitoring Device, vital signs monitor, wrist-watch, external chest compression device, respirator, ECG monitors, defibrillator, pacemaker, pH measurement dresses Put, ultrasonic unit, ECMO/ECLS devices, body chiller, charge pump, gas analyzer for CO2, ventricular assist device, Dialysis apparatuss, touch screen and/or telecommunication installation.

43. according to device in any one of the preceding claims wherein, and the redistribution component includes having for making the trouble Person along head downwards or head is inclined upwardly the component of the inclined part in direction.

44. according to device in any one of the preceding claims wherein, and which also includes for self-checking system, double circuit and uses thing The part of part data record.

45. are controlled with least one other according to device in any one of the preceding claims wherein, wherein described machine element Treat and/or monitoring device communication is to allow the therapy equipment and the behaviour according to device in any one of the preceding claims wherein Work is coordinated.

46. devices according to claim 45, wherein described at least one other treatment and/or monitoring device are selected from heart Resynchronisation therapy equipment, cardioverter defibrillators and cardiac pacemaker.

A kind of 47. methods for providing recovery or halted state in human heart arrest victim, methods described includes making described Patient receives cardiac massage (chest compression), while guaranteeing the kinemic redistribution preferentially to brain and heart blood supply.

48. methods according to claim 47, wherein described redistribution are completed by least one of following：

The aorta of-inaccessible left subclavian artery tail end；

- make patient's head downwards or head is inclined upwardly to reach with respect to the horizontal plane into the angle between 30 and 90 degree；

- put on abdominal part and/or thigh and/or arm to reduce the perfusion in the outside pressing force distally by outside pressing force；

- submissively raise leg to reach relative to the horizontal plane into the angle between 30 and 90 degree.

49. methods according to claim 47 or 48, wherein described chest compression are manual or by using mechanical breast Portion's press device is completed.

50. methods according to any one of claim 47-49, in wherein also processing to below patient offer extremely Few one：

- application of fluid, including saline and buffer such as bicarbonate,

- vasopressor is applied, including vassopressin and analog,

- apply tissue protective agent, such as erythropoietin；

- apply anti-arrhythmic, such as amiodarone；

- body temperature is reduced, such as cooled down by using calm arteries and veins fluid infusion, psychrophore, per nasal evaporation, cool down in vitro or use temperature control Perfluocarbon implements total liquid ventilation.

51. methods according to claim 50, wherein optionally repeatedly provide the process according to fixed order.

52. methods according to any one of claim 47-51, which is included by the inaccessible left subclavian artery tail end The aorta complete redistribution.

53. methods according to claim 52, wherein by by the device according to any one of claim 1-46 Introduce the aorta, preferably via femoral artery, and subsequently by expand the redistribution component of described device and reduce or in Break the blood flow for redistributing component distally to complete obturation.

54. methods according to claim 53, wherein in response to indicating the described device in the patient sustainer The measurement result of inaccessible degree and correct placement, the redistribution component are expanded in a controlled manner.

55. methods according to claim 54, wherein described measurement result are selected from：

The persistent period that-redistribution component expansion is used；

- through the blood flow of the redistribution component；

The blood pressure in-redistribution component the distally, optionally in combination with the blood pressure of the redistribution component nearside；

- redistribution component the distally and preferably in its neighbouring aorta O₂Saturation, it is near optionally in combination with the redistribution component The tremulous pulse O of side₂Saturation.

56. methods according to any one of claim 53-55, the expansion of wherein described redistribution component manually control or The machine element control by described device is incorrect with the incorrect placement or degrees of expansion that avoid described device, and In the case where the incorrect placement of described device is examined by activating fail safe according to claim 9 controlling, from And interrupt the expansion of the redistribution component to allow subsequently correct placement.

57. methods according to any one of claim 47-56, wherein described redistribution are temporary by rule or irregular spacing When interrupt abundant perfusion to guarantee all body parts of the patient.

58. methods according to any one of claim 47-57, methods described are carried out during one or more following, Or serve as following one or more transition：

Therapeutic low temperature；Angioplasty, including PCI and angiography；Dialysis；Apply medicine such as vasopressor, thrombolytic Medicine (such as cellosolve), fluid, bicarbonate, antidote and anti-arrhythmic；Using ultrasound wave, X-ray, CT or MR；Intubation； Mechanical ventilation；Ventricular assist device；Heart transplantation, transplants including artificial heart；Operation, performs the operation including CABG and valve surgery； Blood transfusion；Place outside or inside pacemaker or ICD；Catheter ablation；Thromboendarterectomy；Defibrillation；Transport；ECMO； ECLS and cardiopulmonary bypass.

59. methods according to any one of claim 47-58, methods described also include by using vasodilation, It is sodium nitroprusside or nitroglycerin repetitive administration sodium nitroprusside or nitroglycerin in detail below, hereafter with 2-10 minutes as interval weight It is multiple, reduce the restriction to being delivered to the perfusion of the brain and heart.

60. methods according to claim 59, which also includes preventing by the vasodilation using aortectasia component Caused by medicine, Systemic Vascular withers.

61. according to method in any one of the preceding claims wherein, its also include using it is following any one：Actively press-subtract Pressure CPR, impedance threshold device, administration adenosine, the controlled pauses of CPR (for example pressing 20 seconds, then stop pressing 20 seconds).

62. it is a kind of for by kinemic redistribution to increase supply to brain and heart to sudden cardiac arrest or will the heart The method that the people of dirty all standing provides recovery or halted state, methods described includes making patient receive external chest compression, while guaranteeing to lead to The aorta for crossing the inaccessible left subclavian artery tail end completes the kinemic redistribution, and including by using Vasodilation, is sodium nitroprusside or nitroglycerin in detail below, hereafter repeats to reduce to being delivered to as interval with 2-10 minutes The restriction of the perfusion of the brain and heart.

63. methods according to claim 62, which acts also as following one or more transition：

ECMO；ECLS；Cardiopulmonary bypass；Angioplasty, including PCI and angiography；Dialysis；Therapeutic low temperature, hereafter For calm arteries and veins fluid infusion, psychrophore, per nasal evaporation cooling, external cooling or total liquid ventilation；Medicine is applied, hereinafter Vasopressor or vasodilation, hereinafter sodium nitroprusside or nitroglycerin, Thrombolytic Drugs (such as cellosolve), fluid, bicarbonate, Antidote, organization protection's agent and anti-arrhythmic (such as amiodarone)；Using ultrasound wave, X-ray, CT or MR；Intubation；Machinery is logical Gas；Ventricular assist device；Operation, performs the operation including CABG and valve surgery；Blood transfusion；Place outside or inside pacemaker or ICD；Lead Pipe ablation；Thromboendarterectomy；Heart transplantation；Defibrillation；Transport.

64. it is a kind of for by kinemic redistribution to increase supply to brain and heart to sudden cardiac arrest or will the heart The method that the people of dirty all standing provides recovery or halted state, methods described includes making patient receive external chest compression, while guaranteeing to lead to Cross persistently abdominal compression or abdominal part constraint completes the kinemic redistribution, and including by using vasodilation, under Text is specially sodium nitroprusside or nitroglycerin, hereafter repeats to reduce to being delivered to the brain and heart with 2-10 minutes as interval The restriction of perfusion, and including serving as following one or more transition：ECMO；ECLS；Cardiopulmonary bypass；Angioplasty, bag Include PCI and angiography；Dialysis；Therapeutic low temperature, the arteries and veins fluid infusion of hereinafter cooling down, psychrophore, per nasal evaporation cooling, External cooling or total liquid ventilation；Apply medicine, hereinafter vasopressor or vasodilation, hereinafter sodium nitroprusside or nitre Acid glycerol, Thrombolytic Drugs (such as cellosolve), fluid, bicarbonate, antidote, organization protection's agent and anti-arrhythmic are (such as amine iodine Ketone)；Using ultrasound wave, X-ray, CT or MR；Intubation；Mechanical ventilation；Ventricular assist device；Operation, performs the operation including CABG and lobe Film is performed the operation；Blood transfusion；Place outside or inside pacemaker or ICD；Catheter ablation；Thromboendarterectomy；Heart transplantation； Defibrillation；Transport.

65. is a kind of for hereafter during for example performing the operation or the tissue or organ occur to terminate or subtract in other situations of bleeding The method of few tissue or organ hemorrhage, methods described include for locking device inserting blood vessel to the tissue or organ blood supply, Wherein described locking device is reversible to be expanded with the inaccessible blood vessel and wherein will be put on by the locking device of the expansion described Pressure in blood vessel wall is adapted between 1 and 2 times of the vascular pressure of locking device difference.

66. methods according to claim 65, wherein will be put in the blood vessel wall by the locking device of the expansion Pressure be adapted at most 1.9 times of the vascular pressure difference across the locking device, such as at most 1.8 times, at most 1.7 times, at most 1.6 times, at most 1.5 times, at most 1.4 times, at most 1.3 times, at most 1.2 times and at most 1.1 times.

67. methods according to claim 65 or 66, wherein described locking device include or are attached at least one blood vessel Pressure transducer, the vascular pressure sensor can determine the vascular pressure in the blood vessel.

68. methods according to claim 67, wherein described at least one pressure transducer are placed in the blood vessel Between the occlusion locationses in the blood vessel and the tissue or organ, and/or it is placed in a part for the blood vessel, it is described Part by it is described it is inaccessible with it is described tissue or organ separate.

69. methods according to any one of claim 65-68, wherein described locking device are as in claim 1-46 A part for any one device required for protection, wherein described locking device and aortectasia as claimed in claim 6 Component is consistent or can be the modification shape for being adapted the aortectasia component for enabling to be coupled in other blood vessels Formula.